Dry EyeNCT05573360
Evaluation of Safety and Tolerability of Ocular Lubricants
A study testing NGF5-A test formulation, NGF4-B test formulation and NGF6-B test formulation in people with Dry Eye, run by Alcon Research at 2 sites in Australia.
Trial summary
The purpose of this study is to evaluate the safety profile of test formulations for an artificial tear product versus a comparator product. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- NGF5-A test formulation, NGF4-B test formulation and NGF6-B test formulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 2 sitesAustralia
- Study dates
- 16 Dec 2022to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand and sign an informed consent form.
- Willing and able to attend all study visits as required by the protocol.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Any known active ocular disease.
- Any systemic condition that, in the opinion of the investigator, may affect a study outcome variable.
- Any ocular injury to either eye in the past 12 weeks prior to screening.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Alcon Investigator 8169
Carlton, Victoria, 3053
Alcon Investigator 8214
Waurn Ponds, Victoria, 3216
About this study
The purpose of this study is to evaluate the safety profile of test formulations for an artificial tear product versus a comparator product.
Read the detailed description
Subjects will be randomized to one of five different treatment sequences. Subjects will attend 6 scheduled visits with an expected individual duration of participation of 11 to 42 days. This study will be conducted in Australia.
- Conditions
- Dry Eye
- Being tested
- NGF5-A test formulation, NGF4-B test formulation, NGF6-B test formulation, NGF6-E test formulation, Systane eye drop
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NGF5-A test formulationOther
One drop of investigational product instilled on the eye
NGF4-B test formulationOther
One drop of investigational product instilled on the eye
NGF6-B test formulationOther
One drop of investigational product instilled on the eye
NGF6-E test formulationOther
One drop of investigational product instilled on the eye
Systane eye dropOther
One drop of commercial product instilled on the eye
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Other | NGF5-A/NGF4-B/NGF6-B/NGF6-E/Systane, 1 drop instilled to each eye, with a wash-out period of 1 to 7 days between each instillation Receives: Other: NGF5-A test formulation; Other: NGF4-B test formulation; Other: NGF6-B test formulation; Other: NGF6-E test formulation; Other: Systane eye drop |
| Sequence 2 | Other | NGF4-B/NGF6-B/NGF6-E/Systane/NGF5-A, 1 drop instilled to each eye, with a wash-out period of 1 to 7 days between each instillation Receives: Other: NGF5-A test formulation; Other: NGF4-B test formulation; Other: NGF6-B test formulation; Other: NGF6-E test formulation; Other: Systane eye drop |
| Sequence 3 | Other | NGF6-B/NGF6-E/Systane/NGF5-A/NGF4-B, 1 drop instilled to each eye, with a wash-out period of 1 to 7 days between each instillation Receives: Other: NGF5-A test formulation; Other: NGF4-B test formulation; Other: NGF6-B test formulation; Other: NGF6-E test formulation; Other: Systane eye drop |
| Sequence 4 | Other | NGF6-E/Systane/NGF5-A/NGF4-B/NGF6-B, 1 drop instilled to each eye, with a wash-out period of 1 to 7 days between each instillation Receives: Other: NGF5-A test formulation; Other: NGF4-B test formulation; Other: NGF6-B test formulation; Other: NGF6-E test formulation; Other: Systane eye drop |
| Sequence 5 | Other | Systane/NGF5-A/NGF4-B/NGF6-B/NGF6-E, 1 drop instilled to each eye, with a wash-out period of 1 to 7 days between each instillation Receives: Other: NGF5-A test formulation; Other: NGF4-B test formulation; Other: NGF6-B test formulation; Other: NGF6-E test formulation; Other: Systane eye drop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Treatment-Emergent Adverse Events (AEs)
An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the investigational medical device (test product). The number of adverse events as observed or reported will be recorded.
Measured: Up to Day 30 (Study Exit)
Number of Subjects with Biomicroscopy Findings Outside of Normal Limits
The cornea, conjunctiva, and eyelid will be assessed using a slit lamp. The number of subjects with biomicroscopy findings outside of normal limits will be recorded.
Measured: Screening, up to Day 30 (Study Exit)
Mean Total Ocular Surface Staining Score
Ocular surface staining will be assessed using a slit lamp and recorded on a 15-point scale.
Measured: Screening, up to Day 30 (Study Exit)
Mean Best Corrected Visual Acuity (BCVA)
Visual Acuity will be assessed with correction in place using letter charts. BCVA will be measured in logarithm Minimum Angle of Resolution (logMAR).
Measured: Screening, up to Day 30 (Study Exit)
Number of Device Deficiencies
A device deficiency is inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety, or performance. The number of device deficiencies as observed or reported will be recorded.
Measured: Up to Day 30 (Study Exit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start16 Dec 2022
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Lead, Dry Eye, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05573360
- Sponsor's protocol ID
- DEE253-E001
- Status last verified
- Jul 2023
- First submitted
- 4 Oct 2022
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Tolerability of Ocular Lubricants
- ClinicalTrials.gov ID
- NCT05573360
- Acronym / sponsor ID
- DEE253-E001
- Conditions
- Dry Eye
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety profile of test formulations for an artificial tear product versus a comparator product.
Detailed description
Subjects will be randomized to one of five different treatment sequences. Subjects will attend 6 scheduled visits with an expected individual duration of participation of 11 to 42 days. This study will be conducted in Australia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Other | Other: NGF5-A test formulation, Other: NGF4-B test formulation, Other: NGF6-B test formulation, Other: NGF6-E test formulation, Other: Systane eye dropNGF5-A/NGF4-B/NGF6-B/NGF6-E/Systane, 1 drop instilled to each eye, with a wash-out period of 1 to 7 days between each instillation |
| Sequence 2 | Other | Other: NGF5-A test formulation, Other: NGF4-B test formulation, Other: NGF6-B test formulation, Other: NGF6-E test formulation, Other: Systane eye dropNGF4-B/NGF6-B/NGF6-E/Systane/NGF5-A, 1 drop instilled to each eye, with a wash-out period of 1 to 7 days between each instillation |
| Sequence 3 | Other | Other: NGF5-A test formulation, Other: NGF4-B test formulation, Other: NGF6-B test formulation, Other: NGF6-E test formulation, Other: Systane eye dropNGF6-B/NGF6-E/Systane/NGF5-A/NGF4-B, 1 drop instilled to each eye, with a wash-out period of 1 to 7 days between each instillation |
| Sequence 4 | Other | Other: NGF5-A test formulation, Other: NGF4-B test formulation, Other: NGF6-B test formulation, Other: NGF6-E test formulation, Other: Systane eye dropNGF6-E/Systane/NGF5-A/NGF4-B/NGF6-B, 1 drop instilled to each eye, with a wash-out period of 1 to 7 days between each instillation |
| Sequence 5 | Other | Other: NGF5-A test formulation, Other: NGF4-B test formulation, Other: NGF6-B test formulation, Other: NGF6-E test formulation, Other: Systane eye dropSystane/NGF5-A/NGF4-B/NGF6-B/NGF6-E, 1 drop instilled to each eye, with a wash-out period of 1 to 7 days between each instillation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able to understand and sign an informed consent form.
- Willing and able to attend all study visits as required by the protocol.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (4 listed)
- Any known active ocular disease.
- Any systemic condition that, in the opinion of the investigator, may affect a study outcome variable.
- Any ocular injury to either eye in the past 12 weeks prior to screening.
- Other protocol-defined exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NGF5-A test formulationOne drop of investigational product instilled on the eye | Other | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5 |
| NGF4-B test formulationOne drop of investigational product instilled on the eye | Other | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5 |
| NGF6-B test formulationOne drop of investigational product instilled on the eye | Other | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5 |
| NGF6-E test formulationOne drop of investigational product instilled on the eye | Other | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5 |
| Systane eye dropOne drop of commercial product instilled on the eye | Other | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5 |
Primary outcome
Number of Treatment-Emergent Adverse Events (AEs)
Time frame: Up to Day 30 (Study Exit)
An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the investigational medical device (test product). The number of adverse events as observed or reported will be recorded.
Number of Subjects with Biomicroscopy Findings Outside of Normal Limits
Time frame: Screening, up to Day 30 (Study Exit)
The cornea, conjunctiva, and eyelid will be assessed using a slit lamp. The number of subjects with biomicroscopy findings outside of normal limits will be recorded.
Mean Total Ocular Surface Staining Score
Time frame: Screening, up to Day 30 (Study Exit)
Ocular surface staining will be assessed using a slit lamp and recorded on a 15-point scale.
Mean Best Corrected Visual Acuity (BCVA)
Time frame: Screening, up to Day 30 (Study Exit)
Visual Acuity will be assessed with correction in place using letter charts. BCVA will be measured in logarithm Minimum Angle of Resolution (logMAR).
Number of Device Deficiencies
Time frame: Up to Day 30 (Study Exit)
A device deficiency is inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety, or performance. The number of device deficiencies as observed or reported will be recorded.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Lead, Dry Eye study director
Alcon Research, LLC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NGF5-A test formulation, NGF4-B test formulation and NGF6-B test formulation in people with Dry Eye, run by Alcon Research at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Treatment-Emergent Adverse Events (AEs) (time frame: Up to Day 30 (Study Exit)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2023.